NIDCD Clinical Research Center Grant (P50 Clinical Trial Optional)

NIDCD Clinical Research Center Grant (P50 Clinical Trial Optional) is sponsored by National Institute on Deafness and Other Communication Disorders (NIDCD). Invites applications for Clinical Research Center Grants designed to advance the diagnosis, prevention, treatment, and amelioration of human sensory and communication disorders, including those related to hearing and balance.

Expired PAR-22-025: NIDCD Clinical Research Center Grant (P50 Clinical Trial Optional) This notice has expired. For NIH, in limited situations, applications may be accepted on a case-by-case basis for a short period after expiration to accommodate NIH late or continuous submission policies . Contact the eRA Service Desk for any submission issues.

Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Institute on Deafness and Other Communication Disorders ( NIDCD ) Funding Opportunity Title NIDCD Clinical Research Center Grant (P50 Clinical Trial Optional) Notices of Special Interest associated with this funding opportunity September 15, 2025 - This PAR has been reissued as PAR-25-445 April 04, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025.

See Notice NOT-OD-24-084 July 30, 2024 - Notice to Extend the Expiration Date of PAR-22-025, "NIDCD Clinical Research Center Grant (P50 Clinical Trial Optional)".

See Notice NOT-DC-24-036 NOT-OD-23-012 Reminder: FORMS-H Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022 October 28, 2021 - Reminder: FORMS-G Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2022 - New Grant Application Instructions Now Available.

See Notice NOT-OD-22-018 . September 13, 2021 - Updates to the Non-Discrimination Legal Requirements for NIH Recipients. See Notice August 5, 2021 - New NIH "FORMS-G" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2022.

August 5, 2021 - Update: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements. See Notice NOT-OD-21-170 April 20, 2021 - Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel. See Notice NOT-OD-21-109 Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity See Section III.

3. Additional Information on Eligibility . Assistance Listing Number(s) Funding Opportunity Purpose The National Institute on Deafness and Other Communication Disorders (NIDCD) invites applications for Clinical Research Center Grants designed to advance the diagnosis, prevention, treatment, and amelioration of human communication disorders.

For this announcement, Clinical Research is defined as research involving individuals with communication disorders or data/tissues from individuals with a communication disorder. Examples of such research include but are not limited to, studies of the prevention, pathogenesis, pathophysiology, diagnosis, treatment, management or epidemiology of a disease or disorder of hearing, balance, smell, taste, voice, speech, or language.

Applications may propose a low risk clinical trial but are not required to (optional). Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 30 days prior to the application due date.

Dates in bold and italics reflect changes per NOT-DC-24-036 Application Due Dates Review and Award Cycles New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date February 08, 2022 February 08, 2022 Not Applicable July 2022 October 2022 December 2022 June 07, 2022 June 07, 2022 Not Applicable November 2022 January 2023 April 2023 October 06, 2022 October 06, 2022 Not Applicable March 2023 May 2023 July 2023 February 07, 2023 February 07, 2023 Not Applicable July 2023 October 2023 December 2023 June 06, 2023 June 06, 2023 Not Applicable November 2023 January 2024 April 2024 October 06, 2023 October 06, 2023 Not Applicable March 2024 May 2024 July 2024 February 06, 2024 February 06, 2024 Not Applicable July 2024 October 2024 December 2024 June 06, 2024 June 06, 2024 Not Applicable November 2024 January 2025 April 2025 October 09, 2024 October 09, 2024 Not Applicable March 2025 May 2025 July 2025 February 06, 2025 February 06, 2025 Not Applicable July 2025 October 2025 December 2025 All applications are due by 5:00 PM local time of applicant organization.

All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s). Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

New Date February 07, 2025 (Original Date: October 10, 2024) per issuance of NOT-DC-24-036 Required Application Instructions It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide , except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts ).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review. Part 1. Overview Information Part 2.

Full Text of Announcement Section I. Funding Opportunity Description Section II. Award Information Section III.

Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI.

Award Administration Information Section VII. Agency Contacts Section VIII. Other Information Part 2.

Full Text of Announcement Section I. Funding Opportunity Description The National Institute on Deafness and Other Communication Disorders (NIDCD) at the National Institutes of Health (NIH) invites new or competing applications for Clinical Research Center Grants (P50). This Funding Opportunity Announcement (FOA) targets applicant institutions with demonstrated ability to conduct clinical research in human communication disorders.

Applications are encouraged in the seven scientific programs of the NIDCD: hearing, balance, smell, taste, voice, speech and language. The Clinical Research Center Grant (P50) supports a research program in which an interdisciplinary team of investigators works in a clearly defined central theme of mutual scientific interest.

This mechanism facilitates economy of effort, space, and equipment, and accelerates the acquisition of knowledge by stimulating cooperation among clinical investigators whose projects are directed toward a common goal. For this announcement, Clinical Research is defined as research involving individuals with communication disorders or data/tissues from individuals with a communication disorder.

Examples include (but are not limited to) studies of prevention, pathogenesis, pathophysiology, detection, diagnoses or epidemiology of a disease or disorder of hearing, balance, smell, taste, voice, speech, or language.

A Center must be an identifiable organizational unit with an administrative structure and clear lines of authority in order to facilitate coordination among Center personnel and to assure maximum accountability and efficiency in Center operations. Each proposed Center must have an external advisory committee. The advisory committee will provide oversight of scientific progress of the Center and guide the research plan when appropriate.

The NIDCD P50 must meet 4 essential criteria listed below to be supported: 1. The research to be conducted must be clinical as defined above. 2.

The P50 must have a well-defined central unifying theme consisting of three or more research projects. The P50 may include 1 or more supporting cores as appropriate. Cores are not required or essential criteria, however, the core may be administrative or scientific.

If an administrative core is proposed, the lead of the Administrative Core is also the Director of the Center who is responsible for the organization and overall operation of the Center. 3. Each research project must be unambiguously related to the central unifying theme.

Synergistic and substantial interactions among the projects should be evident. 4. The overall P50 must provide multidisciplinary approaches to the central theme, defined as having research projects representing different disciplines, approaches and expertise.

Studies with normal human subjects (e.g., those without a communication disorder) may be included in the research only when data from normal controls are essential for interpretation of the results. Non-human research will be supported on rare occasions. Non-human research will generally be limited to one project and only if translational or serves as a platform for translational research.

Only one project may be exclusively non-human to be considered for funding. Core support can be requested as part of a P50 application to provide essential resources required by multiple projects, for example, patient management or speech processing technical support etc. A core must serve at least two or more projects.

Requests must be carefully justified and not be used to acquire additional support that duplicates existing resources already at the institution. Research activity is to be conducted in the research projects and is not allowed in the cores; the cores are to serve as infrastructure/support.

The NIH defines a clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. See ( https://grants. nih.

gov/policy/clinical-trials/definition. htm ). This FOA supports only low risk clinical trials.

For the purposes of this FOA, low risk clinical trials must not require FDA oversight, are not intended to formally establish efficacy and have low risks to potentially cause physical or psychological harm.

For the purposes of this FOA, high risk clinical trials are those that require FDA oversight or are intended to formally establish efficacy (NIH-defined Phase III clinical trial) or where the risks to participants are higher than encountered in routine medical or behavioral care or procedures (potential to cause physical or psychological harm).

Applicants considering to conduct high risk clinical trial must use the NIDCD Clinical Trial FOA PAR-21-064 and contact the NIDCD medical officers. All P50 applicants, whether conducting clinical trials or not, are encouraged to contact the P50 Coordinator or the relevant scientific program officer found at the end of this FOA.

Applicants are urged to do so as early in the process of preparing an application as possible especially when considering including a clinical trial to determine the level of risk.

An allowable proposed low risk clinical trial in the P50: Does not require FDA oversight such as those requiring Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications (e.g. clinical trials involving utilization of a licensed product/device for an approved dose, population, and indication may not require an IND or IDE) Does not include an intervention with the potential to cause physical or psychological harm greater than what is encountered in routine medical or behavioral care or procedures Intends to gather scientific data/evidence to inform subsequent studies but not aimed or sufficiently powered to directly change health policy or standard of care and is not an NIH defined Phase III Clinical Trial ( https://humansubjects.

nih. gov/glossary ). See Section VIII.

Other Information for award authorities and regulations. Section II. Award Information Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA. Optional: Accepting applications that either propose or do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Budgets for new applications are limited to $1,500,000.

00/per year direct costs (DC), exclusive of consortium facilities and administrative costs. Renewal (type 2) grant applications may request budgets (DC) that are not greater than 10% above the budget of the last year of the existing award or $2,000,000. 00 whichever is less; this is also exclusive of consortium, facilities and administrative costs.

Salary levels in all years are limited to the NIH maximum rate. Revision applications requesting an additional research component to an existing P50 may not exceed the duration of the parent award or the budgetary caps as described above. Future year amounts will depend on annual appropriations.

The maximum project period is 5 years. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA. Section III.

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education: Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) Eligible Agencies of the Federal Government U.S. Territory or Possession Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are allowed. Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award.

All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.

System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.

gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application. Grants.

gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants. gov registration. Program Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account.

PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator) Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support.

Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement . 3. Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2. 3. 7.

4 Submission of Resubmission Application . This means that the NIH will not accept: A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application. A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see 2. 3. 9.

4 Similar, Essentially Identical, or Identical Applications ). Renewals must be submitted only after a minimum of 4 years of the project have been completed. Applications submitted before 4 years of funding have been completed will be withdrawn and not reviewed.

Section IV. Application and Submission Information 1. Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution.

A button to apply using ASSIST is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution. 2.

Content and Form of Application Submission It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide , except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants. gov downloadable forms currently used with most NIH opportunities.

Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1.

Overview Information , prospective applicants are asked to submit a letter of intent that includes the following information: Descriptive title of proposed activity Name(s), address(es), and telephone number(s) of the PD(s)/PI(s) Names of other key personnel Participating institution(s) Number and title of this funding opportunity The letter of intent should be sent to: All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Component Type for Submission Instructions for the Submission of Multi-Component Applications The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application. Revision applications must include an Overall component and the components that are affected by the revision.

Therefore, the component requirements listed below may not apply to the revision application. The application should consist of the following components: For new applications and resubmission of a new application, in order not to restrict the pool of available scientific peer reviewers, you should not invite or name in your application potential members of your Advisory Committee.

When preparing your application, use Component Type Overall . All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted. SF424(R&R) Cover (Overall) PHS 398 Cover Page Supplement (Overall) Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall) Follow standard instructions. Project/Performance Site Locations (Overall) A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research and Related Senior/Key Person Profile (Overall) Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application. A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover. A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall) Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing (DMS) Plan will be attached in the Other Plan(s) attachment of the Overall Component in FORMS-H and subsequent application forms packages.

For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages. All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan.

All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. The Data Management and Sharing (DMS) Plan must be provided in the Overall component. Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

Specific Aims : Specific Aims are required. Provide an overview of the entire research program and describe the defined central theme and goals of the Clinical Research Center (P50). Provide the rationale for the proposed research program.

Include potential impact, any areas of special interest, and any research ideas, disease entities, and target populations to be studied. Explain the research plan for achieving the objective(s) of the overall research program and how each research project and core relates to that overall plan.

Research Strategy: Explain how this Clinical Research Center Grant (P50) application supports an investigator-initiated research program in which a multidisciplinary team of investigators works in a clearly defined central theme of mutual scientific interest.

Describe how this effort facilitates economy of effort, space, and equipment, and accelerates the acquisition of knowledge by stimulating cooperation among clinical investigators whose projects are directed toward a common goal. Describe how this overall Research Center will provide a whole that will have an impact beyond simply the sum of its parts.

Describe how the research focuses on individuals with communication disorders or data/tissues from individuals with a communication disorder.

Indicate any prior collaborative arrangements between investigators in the group; emphasizing the events that led to the current application; predict the anticipated advantages that would be gained by including the research in the proposed program; describe the overall theme of the Center and how research subprojects are related to the theme; and describe the multidisciplinary nature of the proposed research.

Letters of Support: Include any letters of support for the proposed Center by appropriate institutional officials of each performance site. These letters should include commitments of space and other resources required by the Center. A letter of agreement from existing resources (such as the CTSA PD(s)/PI(s)) should be included here if collaborative linkages are being developed between the Center and the existing resources.

Resource Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide. The following modifications also apply: All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. Only limited items are allowed in the Appendix.

Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall) When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions: If you answered Yes to the question Are Human Subjects Involved?

on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components.

To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components. Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the SF424 (R&R) Application Guide must be followed.

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed. PHS Assignment Request Form (Overall) All instructions in the SF424 (R&R) Application Guide must be followed.

Administrative Core (Optional) When preparing your application, use Component Type Administrative Core. All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Administrative Core ) Complete only the following fields: Type of Applicant (optional) Descriptive Title of Applicant’s Project Proposed Project Start/Ending Dates PHS 398 Cover Page Supplement (Administrative Core) Enter Human Embryonic Stem Cells in each relevant component. Research & Related Other Project Information (Administrative Core) Human Subjects: Answer only the Are Human Subjects Involved?

and 'Is the Project Exempt from Federal regulations? questions. Vertebrate Animals: Answer only the Are Vertebrate Animals Used?

question. Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required.

However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components. Project /Performance Site Location(s) (Administrative Core) List all performance sites that apply to the specific component. Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administrative Core) In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field. In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.

Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component. If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Administrative Core) Budget forms appropriate for the specific component will be included in the application package. Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Administrative Core) Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component. Specific Aims: Describe how the Administrative Core administration will coordinate and manage activities across the components of the Research Center.

Research Strategy: Describe the organizational framework for the management, direction and coordination of the Center to ensure that all proposed components and related activities will function in an optimal and synergistic manner. Include information on how this core will facilitate administration of the budget.

This core should be described in sufficient detail to assure that all proposed components and related activities will function optimally. In addition, day-to-day operations involving procurement, finances, personnel, planning, and budgeting should be detailed in the description of this core. Describe how the Administrative Core will enhance the overall research of the Center.

The PD/PI provides scientific and administrative leadership for the Center, so the PD/PI must have a demonstrated ability to coordinate, integrate, and provide guidance in establishing multi-faceted research programs.

Describe the administrative framework to manage the Research Center and each core, including the roles of the Research Center/Administrative Core Director and Research Projects and Scientific Core Directors, the lines of authority and relationship to appropriate institutional officials, how access and utilization of services will be prioritized, how potential disputes will be resolved, and how periodic evaluations will be used to improve the services.

Describe how the proposed Administrative Core will foster close interactions among the various component Directors and other appropriate institutional administrative personnel. The Advisory Committee should be actively involved in the evaluation and planning process of the Center.

The Advisory Committee should meet formally at least annually to assist the Center Directors in evaluating the scientific progress and optimizing strategies to meet its overall research goals over the course of the grant award. Letters of Support: Provide letters of support from outside consultants as needed.

For new applications and resubmission of a new application, do not include letters for External Advisory Committee members as they will be named after an award is made. If these documents are included in the Overall component, please state so.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification: The following modifications also apply: All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. Only limited items are allowed in the Appendix.

Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Administrative Core) When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424